Hypopharyngeal Peak PressureNCT07594561
Normative Swallowing Physiological Metrics of Pharyngeal High-Resolution Impedance Manometry in Chinese Adults
An observational study of Hypopharyngeal Peak Pressure, run by National Taiwan University Hospital.
Trial summary
As Taiwan enters a super-aged society in 2025, the number of elderly patients and patients with multiple comorbidities continues to increase, and the risk of dysphagia rises with advancing age. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypopharyngeal Peak Pressure
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 20 May 2026to 31 Dec 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: normal patients withour dysphagia
Who may be able to join
- Adults aged 18 years or older without subjective swallowing difficulty.
Who cannot join
- (1) Major systemic diseases, including heart failure, liver cirrhosis, end-stage renal disease, scleroderma, or diabetes mellitus; (2) History of vasovagal syncope, acute inflammation, or nasal or esophageal stenosis/obstruction; (3) Presence of upper gastrointestinal symptoms within the past 3 months, including dysphagia, chest pain, heartburn, reflux, or globus sensation; (4) Current use of medications that may affect gastrointestinal motility; (5) Use of anticoagulant or antiplatelet agents within 1 week prior to enrollment; or (6) History of bleeding tendency.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Normative Swallowing Physiological Metrics of Pharyngeal High-Resolution Impedance Manometry and Videofluoroscopic Swallowing Study in Chinese Adults
As Taiwan enters a super-aged society in 2025, the number of elderly patients and patients with multiple comorbidities continues to increase, and the risk of dysphagia rises with advancing age. Due to neuronal degeneration and muscle atrophy, older adults often experience delayed recovery of swallowing function after general anesthesia, and it may take up to seven days to regain their baseline swallowing ability. Therefore, postoperative monitoring of swallowing function and early rehabilitative intervention are crucial for reducing complication risks and facilitating early discharge.
Currently, there is limited literature regarding normative data for pharyngeal swallowing assessment using high-resolution pharyngeal manometry with impedance as well as videofluoroscopic swallowing studies in the Chinese population. This project aims to recruit 80 healthy adults to establish normative reference values.
Read the detailed description
To ensure relative consistency in the physiological, pathological, and psychological conditions of participants, this study will recruit 80 healthy adults without swallowing difficulties using convenience sampling from outpatient clinics and the general healthy population at National Taiwan University Hospital (NTUH). All participants will undergo both videofluoroscopic swallowing study (VFSS) and high-resolution pharyngeal manometry with impedance (HRIM). Inclusion criteria include adults aged ≥18 years without subjective dysphagia. Exclusion criteria include major systemic diseases (e.g., heart failure, liver cirrhosis, end-stage renal disease, scleroderma, or diabetes mellitus), history of vasovagal syncope, acute inflammation, nasal or esophageal stenosis/obstruction, upper gastrointestinal symptoms within the past 3 months, use of medications affecting gastrointestinal motility, recent anticoagulant or antiplatelet use within 1 week before enrollment, or bleeding tendency. After informed consent is obtained, participants will fast for 4-8 hours before testing. Assessments will include a rapid swallowing test, anthropometric measurements and InBody analysis, limb ultrasound and muscle strength evaluation using the MicroFET2™ wireless handheld dynamometer and handgrip dynamometer, ultrasonographic assessment of hyoid bone movement and swallowing-related muscles (e.g., masseter muscle), HRIM and VFSS examinations, and blood sampling (5 cc) for biochemical analysis including LDL, HDL, cholesterol, white blood cell count, and hemoglobin.
- Conditions
- Hypopharyngeal Peak Pressure
- Keywords
- normal value, high resolution impedance manometry
What is being measured
The primary outcome is the main question the study is designed to answer.
hypopharyngeal mean peak pressure
pharyngeal contraction
Measured: 15 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start20 May 2026 (estimated)
- Primary completion31 Dec 2031 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypopharyngeal Peak PressureStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07594561
- Sponsor's protocol ID
- 202603162RINA
- Status last verified
- May 2026
- First submitted
- 13 May 2026
- Last updated
- 19 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Normative Swallowing Physiological Metrics of Pharyngeal High-Resolution Impedance Manometry and Videofluoroscopic Swallowing Study in Chinese Adults
- ClinicalTrials.gov ID
- NCT07594561
- Acronym / sponsor ID
- 202603162RINA
- Conditions
- Hypopharyngeal Peak Pressure
- Keywords
- normal value, high resolution impedance manometry
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 20 May 2026 (estimated)
- Primary completion
- 31 Dec 2031 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 19 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
As Taiwan enters a super-aged society in 2025, the number of elderly patients and patients with multiple comorbidities continues to increase, and the risk of dysphagia rises with advancing age. Due to neuronal degeneration and muscle atrophy, older adults often experience delayed recovery of swallowing function after general anesthesia, and it may take up to seven days to regain their baseline swallowing ability. Therefore, postoperative monitoring of swallowing function and early rehabilitative intervention are crucial for reducing complication risks and facilitating early discharge.
Currently, there is limited literature regarding normative data for pharyngeal swallowing assessment using high-resolution pharyngeal manometry with impedance as well as videofluoroscopic swallowing studies in the Chinese population. This project aims to recruit 80 healthy adults to establish normative reference values.
Detailed description
To ensure relative consistency in the physiological, pathological, and psychological conditions of participants, this study will recruit 80 healthy adults without swallowing difficulties using convenience sampling from outpatient clinics and the general healthy population at National Taiwan University Hospital (NTUH). All participants will undergo both videofluoroscopic swallowing study (VFSS) and high-resolution pharyngeal manometry with impedance (HRIM). Inclusion criteria include adults aged ≥18 years without subjective dysphagia. Exclusion criteria include major systemic diseases (e.g., heart failure, liver cirrhosis, end-stage renal disease, scleroderma, or diabetes mellitus), history of vasovagal syncope, acute inflammation, nasal or esophageal stenosis/obstruction, upper gastrointestinal symptoms within the past 3 months, use of medications affecting gastrointestinal motility, recent anticoagulant or antiplatelet use within 1 week before enrollment, or bleeding tendency. After informed consent is obtained, participants will fast for 4-8 hours before testing. Assessments will include a rapid swallowing test, anthropometric measurements and InBody analysis, limb ultrasound and muscle strength evaluation using the MicroFET2™ wireless handheld dynamometer and handgrip dynamometer, ultrasonographic assessment of hyoid bone movement and swallowing-related muscles (e.g., masseter muscle), HRIM and VFSS examinations, and blood sampling (5 cc) for biochemical analysis including LDL, HDL, cholesterol, white blood cell count, and hemoglobin.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- normal patients withour dysphagia
Key inclusion criteria (1 listed)
- Adults aged 18 years or older without subjective swallowing difficulty.
Key exclusion criteria (1 listed)
- (1) Major systemic diseases, including heart failure, liver cirrhosis, end-stage renal disease, scleroderma, or diabetes mellitus; (2) History of vasovagal syncope, acute inflammation, or nasal or esophageal stenosis/obstruction; (3) Presence of upper gastrointestinal symptoms within the past 3 months, including dysphagia, chest pain, heartburn, reflux, or globus sensation; (4) Current use of medications that may affect gastrointestinal motility; (5) Use of anticoagulant or antiplatelet agents within 1 week prior to enrollment; or (6) History of bleeding tendency.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
hypopharyngeal mean peak pressure
Time frame: 15 min
pharyngeal contraction
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypopharyngeal Peak Pressure, run by National Taiwan University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chi-Jun Lai (0972652086, littlecherrytw@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hypopharyngeal mean peak pressure (time frame: 15 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.